ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 14 for:    Recruiting, Not yet recruiting, Available Studies | "Thoracic Diseases"

Needlescopic-assisted Uniportal vs Uniportal VATS (UNeed Trail)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03439696
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch

Brief Summary:
The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under assistance of needlescopic instruments through additional 2-3 mm ports compared to conventional uniportal VATS in patients with lung lesions.

Condition or disease Intervention/treatment Phase
Lung Cancer Lung Cancer Metastatic Bullous Disease Lung Nodule Solitary Pulmonary Mediastinal Tumor Procedure: Thoracoscopic surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Needlescopic-assisted Uniportal VATS Versus Conventional Uniportal VATS. A Randomized Prospective Noninferiority Study
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Needlescopic-assisted
Thoracoscopic surgery performed with the fashion of single 2.5-3.5 cm intercostal incision and 1-2 additional 2-3 mmm needlescopic ports.
Procedure: Thoracoscopic surgery
Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

Active Comparator: Uniportal
Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision
Procedure: Thoracoscopic surgery
Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.




Primary Outcome Measures :
  1. Pain scale POD 3 [ Time Frame: 3 days ]
    Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)

  2. Pain scale POD 5 [ Time Frame: 5 days ]
    Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)

  3. Hospital stay [ Time Frame: 14 days ]
    Post-operative hospital stay

  4. Post-operative 3 month neuralgia [ Time Frame: 3 months ]
    Out patient documented using PainDETECT questionnaire (PD-Q)

  5. Post-operative 6 month neuralgia [ Time Frame: 6 months ]
    Out patient documented using PainDETECT questionnaire (PD-Q)


Secondary Outcome Measures :
  1. Cost [ Time Frame: 14 days ]
    Total hospital cost

  2. Surgical time [ Time Frame: 1 day ]
    Time spend in surgery

  3. Surgical bleeding [ Time Frame: 1 day ]
    Blood loss during operation

  4. Opioid using dosage [ Time Frame: 14 days ]
    Total opioid equivalent dose used during post-operative course



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion Criteria:

Thoracoscopic esophagectomy Decortication for empyema


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439696


Contacts
Contact: Shun-Mao Yang, MD 886-3-5326151 ext 8394 mutayang@gmail.com
Contact: Huan-Jang Ko, MD 886-3-5326151 ext 8394 kaba@ms1.hinet.net

Locations
Taiwan
National Taiwan University Hospital, Hsin-Chu Branch Recruiting
Taipei, Hsin-Chu County, Taiwan, 30059
Contact: Chiu-kuei Nien    886-3-5326151    hch01215@hch.gov.tw   
Sponsors and Collaborators
IRB of NTUH Hsin-Chu Branch
Investigators
Principal Investigator: Chiu-kuei Nien National Taiwan University Hospital Hsinchu Branch

Responsible Party: IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch
ClinicalTrials.gov Identifier: NCT03439696     History of Changes
Other Study ID Numbers: 106-067-F
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch:
Thoracoscopy
VATS
Needlescopy
Uniportal

Additional relevant MeSH terms:
Lung Neoplasms
Mediastinal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Mediastinal Diseases
Thoracic Diseases